[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Alpha Biopharma (Jiangsu) Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":94},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100620752","phase-1-zorifertinib-with-osimertinib-for-nsclc-with-meningeal-progression-100620752",false,"NCT07361705","Zorifertinib With Osimertinib for NSCLC With Meningeal Progression","An Open-Label, Multicentre, Phase 1 Clinical Study to Evaluate the Safety and Efficacy of Zorifertinib Combined With Osimertinib in Patients With Advanced Non-Small Cell Lung Cancer With Meningeal Progression After Osimertinib Treatment","Inclusion Criteria:\n\nFor inclusion in the study, patients must meet all of the following criteria.\n\n1. The patient or the guardian is required to understand and sign the informed consent form of this study.\n2. During the screening period, subjects must have a previous histological or cytological diagnosis of NSCLC with a sensitising EGFR mutation (including L858R and\u002For Exon19Del).\n3. Only patients who have developed meningeal progression after osimertinib treatment (at a standard dose of 80 mg QD; if the dose is 160 mg QD, it must be reduced to 80 mg QD for at least 1 week before receiving study treatment) (new-onset meningeal progression, or patients with existing meningeal progression that is poorly controlled using osimertinib combined with available conventional treatment \\[CNS symptoms not relieved or CSF cytology not turning negative\\], but the available conventional treatment must be washed out for at least 4 weeks) and have no extracranial progression are allowed to be enrolled.\n4. Subjects with leptomeningeal metastases should have the positive results of cerebrospinal fluid (CSF) cytology. Subjects with negative CSF cytology but highly suspected of leptomeningeal metastases in combination with CSF biochemical test and brain or spinal cord MRI imaging examination are allowed to be enrolled into the study.\n5. Subjects with meningeal progression and brain parenchyma progression are allowed to be enrolled.\n6. Subjects must have at least one repeatedly evaluable, measurable target lesion (intracranial and\u002For extracranial) according to mRECIST 1.1 criteria or a repeatedly evaluable lesion according to RANO-LM criteria.\n7. Subjects must be ≥ 18 years old before signing the informed consent form (ICF).\n8. If there are neurological symptoms, the following conditions must be met: Able to take and swallow oral medication; No need to increase the hormone dose to enhance control of central nervous system symptoms for at least 1 week before study treatment. If a patient is taking hormone for the purpose of treating endocrine dysfunction or tumor-related symptoms (not central nervous system-related), the dose must be stable or reduced within 5 days before the study medication. Note: The hormone dose should be stable 5 days before the baseline brain MRI.\n9. All toxicities related to anti-tumor therapy (including radiotherapy) must have resolved to ≤ Grade 1 (CTCAE 5.0, it is sufficient for neurotoxicity related to platinum treatment to resolve to ≤ Grade 2 \\[CTCAE\\]) before starting the study treatment. Patients with alopecia of any grade are allowed to be enrolled.\n10. The screening period examination of patients must meet the followings:\n\n    * Neutrophil count ≥ 1.5 x 109\u002FL\n    * Platelet ≥ 100 x 109\u002FL\n    * Hemoglobin ≥ 9 g\u002FdL\n    * Blood creatinine ≤ 1.5 x ULN, or creatinine clearance (Cockcroft-Gault formula) ≥ 50 mL\u002Fmin\n    * Total bilirubin ≤ 1.5 x ULN (for patients with Gilbert's syndrome or metastases to liver, ≤3 x ULN is acceptable)\n    * Glutamic-oxaloacetic transferase ≤ 2 x ULN (for patients with metastases to liver, ≤ 3 x ULN is acceptable)\n    * Glutamic-pyruvic transaminase ≤ 2 x ULN (for patients with metastases to liver, ≤ 3 x ULN is acceptable)\n11. The estimated survival time of subjects is ≥ 6 weeks.\n12. Karnofsky Performance Status (KPS) scale score ≥ 60.\n\nExclusion Criteria:\n\nPatients must not enter the study if any of the following exclusion criteria is met:\n\n1. Subjects who plan to receive brain radiotherapy or intrathecal injection during the period from signing ICF to study medication.\n2. Radiotherapy history within 28 days before study drug administration is not allowed for enrollment, and palliative radiation to the skeleton occurring within 14 days before study drug administration is also not allowed for enrollment.\n3. Subjects who have undergone major surgery (e.g. intrathoracic, intraperitoneal or pelvic surgery) within 4 weeks prior to the first dose of study treatment or who have not yet recovered from the side effects associated with such surgery are not allowed to be enrolled.\n4. In addition to NSCLC, there are other malignant tumors, or a history of other malignant tumors within 5 years, except for the following cases: Complete resection of skin basal cell and squamous cell carcinoma and radical resection of any type of carcinoma in situ.\n5. Suffering from clinically significant and uncontrollable cardiac disorder and\u002For heart-related events within 6 months, such as:\n\n(1) Unstable angina within 6 months before the screening period; (2) Myocardial infarction within 6 months before the screening period; (3) Documented history of heart failure (NYHA Class III-IV) or left ventricular ejection fraction (LVEF) \\\u003C 50%; (4) Uncontrollable hypertension: systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg, with or without antihypertensive drug treatment; the drugs are allowed to be adjusted before the screening period; (5) Ventricular arrhythmia; (6) Supraventricular or sinus arrhythmias but difficult to control with drugs; (7) Arrhythmias that cannot be controlled by other drugs; (8) QTcF \\>470 ms (mean value of three readings corrected using the Fridericia formula) during the screening period.\n\n(9) The patient has any factors that increase the risk of QTc prolongation or arrhythmic events, such as electrolyte disturbances, including: Grade 2 or higher hypokalemia according to CTCAE (electrolyte disturbances should be corrected to ≤Grade 1 according to CTCAE and documented before the first dose); heart failure, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death in a first-degree relative under the age of 40, or any concomitant medication known to prolong the QT interval and lead to torsades de pointes.\n\n6\\. Suffering from gastrointestinal disorders or serious impairment of gastrointestinal function, which may significantly affect drug absorption (e.g. ulcerative diseases, uncontrollable nausea, or vomiting, diarrhea, or malabsorption syndrome).\n\n7\\. Unable to discontinue the following medications before the start of the study drug and during the study according to the withdrawal period provided in Appendix 13.6 (see Appendix 13.6 for specific withdrawal periods):\n\n1. Strong CYP3A4 inducers or inhibitors;\n2. Drugs mainly metabolised by CYP3A4;\n3. Drugs that may cause QT interval prolongation or torsade de pointe. 8. Patients with a previous or concurrent HIV infection are not allowed to enroll. Patients who are HCV antibody positive can be enrolled if HCV-RNA is undetectable (the lower limit of normal for HCV-RNA detection is based on the test values of each site) and there is no concurrent hepatitis B virus (HBV) infection. HBV-infected individuals are allowed to be enrolled if they meet the following criteria: 1) Patients with active hepatitis B must meet the following conditions: Antiviral treatment is given for at least 6 weeks before starting study treatment, HBV DNA must be \\\u003C100 IU\u002FmL, and ALT and AST levels must be \\\u003CULN; 2) Patients with resolved hepatitis B or chronic hepatitis B must meet the following criteria: Patients have received prophylactic antiviral treatment for at least 2-4 weeks before the start of study treatment, transaminases have been below ULN for \\>6 months, and HBV DNA is below 100 IU\u002FmL (if in an inactive carrier state) 9. Women who are pregnant or lactating. Women of childbearing potential are required to use highly effective contraceptive methods during the dosing period and for 3 months after discontinuation of the drug. Fertile males must also use highly effective contraceptive methods during the dosing period and for 6 months after discontinuation of the drug.\n\nA woman of child-bearing potential is defined as a non-postmenopausal woman who has experienced menarche and has not undergone sterilization (hysterectomy or bilateral salpingo-oophorectomy) or has no other causes of permanent infertility (such as Mullerian agenesis) determined by the investigator. Postmenopause is defined as amenorrhea ≥ 12 months without other biological or physiological reasons.\n\n10\\. Due to existence of other serious, acute or chronic medical diseases (e.g. uncontrollable diabetes or psychic disorder or abnormal laboratory tests), the investigators judged that participating in the study treatment may bring more risks to the subjects or make it difficult to explain the study results.\n\n11\\. Previously suffering from interstitial lung disease, including clinically significant radiation pneumonia (e.g. affecting daily life or requiring treatment intervention).\n\n12\\. Subjects who have previously received treatment with zorifertinib drug product or drug substance.\n\n13\\. A clear known history of allergy to the active ingredient or excipients of zorifertinib or to drugs with a chemical structure or class similar to zorifertinib.\n\n14\\. Due to other combined diseases or other factors, investigators judged that participating in the clinical trial may bring greater risks to subjects.","ALL","18 Years",{"count":19,"type":20},42,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a clinical trial that aims to test Zorifertinib when used together with a known drug, Osimertinib. The goal is to learn if this combination is safe and works for people with advanced Non-Small Cell Lung Cancer (NSCLC) whose cancer has spread to the membranes surrounding the brain and spinal cord (a condition called leptomeningeal metastases) after being treated with Osimertinib.",[26],"Patients With Advanced Non-small Cell Lung Cancer With Meningeal Progression After Osimertinib Treatment",[28,29,30,31,32,33],"NSCLC","Leptomeningeal Metastases","Leptomeningeal Carcinomatosis","Meningeal Metastases","EGFR","Osimertinib, Zorifertinib","RECRUITING","2026-06-18",{"date":37,"type":38},"2026-06-22","ACTUAL",{"date":40,"type":38},"2026-01-31",{"date":42,"type":20},"2028-09-15",{"name":44,"class":45},"Alpha Biopharma (Jiangsu) Co., Ltd.","INDUSTRY",5,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":55,"minAge":17,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100639103","phase-1-material-balance-of-14czorifertinib-in-healthy-adult-male-participants-in-china-100639103","NCT07620951","Material Balance of [14C]Zorifertinib in Healthy Adult Male Participants in China","Phase I Clinical Study on Material Balance of [14C]Zorifertinib in Healthy Adult Male Participants in China","Inclusion Criteria:\n\n1. Healthy Chinese males;\n2. Age at the time of signing the informed consent form: 18-45 years (inclusive);\n3. Body mass index (BMI) ranging from 19-26 kg\u002Fm2 (inclusive), with a body weight of no less than 50 kg;\n4. Fully understand the purpose and requirements of this study and voluntarily sign the informed consent form;\n5. Be able to communicate well with the investigators and complete the trial according to the protocol.\n6. The 14C content in plasma and urine samples obtained during screening are within general environmental 14C background levels. Directly analyzed plasma samples must have values ≤150 pMC, and urine samples containing petroleum-based carbon carriers must have values ≤50 pMC.\n\nExclusion Criteria:\n\nAncillary Examinations:\n\n1. Abnormal findings from comprehensive physical examination, vital signs, laboratory tests (hematology, blood biochemistry, coagulation function, urinalysis, routine stool + occult blood, thyroid function), 12-lead ECG, chest X-ray (posteroanterior view), abdominal ultrasound, digital rectal examination, etc., that are judged by the investigator as clinically significant.\n2. Resting corrected QT interval (Fridericia correction, QTcF = QT\u002FRR1\u002F3) obtained from 12-lead ECG \\>450 ms in males, or other abnormalities judged by the investigator as clinically significant.\n3. Positive result for any of the following: hepatitis B surface antigen or hepatitis B e antigen, hepatitis C virus antibody, Treponema pallidum antibody, or human immunodeficiency virus antigen\u002Fantibody combination test (HIV-Ag\u002FAb).\n4. Abnormal findings from ophthalmic examination (slit lamp, intraocular pressure, fundus photography) that are clinically significant.\n\n   Medication History:\n5. Use of any drugs that inhibit or induce the drug-metabolizing enzyme CYP3A4 within 30 days prior to the screening period.\n6. Use of any prescription drugs, over-the-counter drugs, herbal medicines, or food supplements (e.g., vitamins, calcium supplements) within 14 days prior to the screening period.\n\n   Medical and Surgical History:\n7. History of any clinically serious disease or condition that the investigator believes may affect the trial results, including but not limited to circulatory, respiratory, endocrine, nervous, digestive, urinary, hematologic, immune, psychiatric, or metabolic diseases;\n8. History of dysphagia or any condition that may affect drug absorption, e.g., gastrectomy, cholecystectomy, gastric bypass, duodenotomy, colectomy, inflammatory bowel disease;\n9. History of organic heart disease, heart failure, myocardial infarction, angina pectoris, arrhythmia, ventricular tachycardia, clinically symptomatic AV block, long QT syndrome, or family history of long QT syndrome (evidenced by genetic proof or sudden cardiac death of a close relative at a young age);\n10. Major surgery within 6 months prior to the screening period, or surgical incision not fully healed; Major surgery includes, but is not limited to, any procedure with significant bleeding risk, prolonged general anesthesia, incisional biopsy, or significant traumatic injury;\n11. Allergic constitution, e.g., known history of allergy to two or more substances; Or judged by the investigator as potentially allergic to the investigational drug;\n12. Hemorrhoids or perianal diseases with regular\u002Fongoing hematochezia, irritable bowel syndrome, inflammatory bowel disease.\n\n    Lifestyle Habits:\n13. Habitual constipation or diarrhea;\n14. Alcoholism or regular alcohol consumption within 6 months prior to screening, i.e., alcohol intake exceeding 14 units per week (1 unit = 360 mL beer, or 45 mL spirit with 40% alcohol, or 150 mL wine), or a breath alcohol test result ≥20 mg\u002FdL at screening, or inability to abstain from alcohol during the trial period;\n15. Smoking \\>5 cigarettes per day or habitual use of nicotine-containing products within 3 months prior to screening, or inability to abstain during the trial period;\n16. Drug abuse or use of soft drugs (e.g., cannabis) within 3 months prior to screening, or use of hard drugs (e.g., amphetamines, phencyclidine) within 1 year prior to screening; Or positive urine screen for drugs of abuse during the screening period;\n17. Habitual consumption of grapefruit juice or excessive tea, coffee, and\u002For caffeinated beverages, and inability to abstain during the study period.\n\n    Others:\n18. Participation in a radiolabeled drug trial within 1 year prior to screening, or participation in a 14C-labeled breath test within 3 months prior to screening;\n19. History of needle phobia or blood phobia, difficulty with blood collection, or inability to tolerate venous puncture;\n20. Participation in any other clinical trial (including drug and device trials) within 3 months prior to the screening period;\n21. Vaccination within 1 month prior to screening, or planned vaccination during the study period;\n22. Plan to father a child or donate sperm during the study period or within 1 year after study completion, or disagreement to use strict contraceptive measures (see Appendix 1) for themselves and their partners during the study period and within 1 year after study completion;\n23. Blood loss or blood donation of ≥400 mL within 3 months prior to screening, or blood transfusion within 1 month;\n24. Any other factor that, in the investigator's opinion, makes the participant unsuitable for participation in this trial.",true,"MALE","45 Years",{"count":58,"type":20},8,[23],"This is a single-center, single-dose, open-label, Phase I study to evaluate the mass balance, biotransformation, pharmacokinetic characteristics, excretion pathways, and safety of a single oral 200 mg\u002F5 µCi dose of \\[14C\\]Zorifertinib in healthy Chinese adult male participants. The study includes a screening period (Day -14 to Day -1) and a dosing and observation period (Day 1 to Day 14). Blood, urine, and feces samples will be collected to measure radioactivity, drug concentrations, and metabolites. Safety will be assessed by adverse events, vital signs, laboratory tests, 12-lead ECG, and ophthalmic examinations. The target total radioactivity recovery is ≥90% of the administered dose.",[62,63],"EGFR Mutant Advanced Non-small Cell Lung Cancer","Central Nervous System (CNS) Metastases","NOT_YET_RECRUITING","2026-06-01",{"date":67,"type":38},"2026-06-03",{"date":69,"type":20},"2026-06",{"date":71,"type":20},"2026-08",{"name":44,"class":45},1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},"100603940","a-prospective-cohort-study-of-zorifertinib-as-a-first-line-treatment-in-patients-with-epidermal-growth-factor-receptor-mutant-advanced-non-small-cell-lung-cancer-with-central-nervous-system-cns-metastases-100603940","NCT07143045","A Prospective Cohort Study of Zorifertinib as a First-line Treatment in Patients With Epidermal Growth Factor Receptor-mutant Advanced Non-small Cell Lung Cancer With Central Nervous System (CNS) Metastases","Inclusion criteria:\n\n1. Male or female, aged ≥18 years.\n2. Histologically or cytologically confirmed NSCLC with EGFR sensitizing mutations (including L858R or Exon 19Del), ineligible for curative surgery or radiotherapy.\n3. CNS metastases diagnosed as brain metastases (BM) and\u002For leptomeningeal metastases (LM) by imaging and\u002For cerebrospinal fluid pathological examination.\n4. Planning to receive zorifertinib (zorifertinib group) or other anti-tumor treatments (other treatment group) as first-line treatment.\n5. Voluntarily agreeing to participate in this study and signing the informed consent form.\n\nExclusion criteria:\n\n1. Currently participating or planning to participate in any interventional clinical study for first-line treatment (patients who have participated in non-interventional, real-world studies may still be included).\n2. Other reasons that, in the Investigator's opinion, make the patient unsuitable for this study.\n\nFor patients in Cohort A of the zorifertinib group, the following inclusion\u002Fexclusion criteria of the EVEREST study must also be met:\n\nInclusion Criteria A:\n\n1. . No prior treatment with chemotherapy, EGFR-TKIs, biological therapy, immunotherapy, or any investigational drug that is considered first line treatment for advanced NSCLC.\n2. . Eligible patients are not candidates for definitive surgical resection or radiation of all lesions in the opinion of the treating physician.\n3. . All patients must be stable without any systemic (oral or parenteral) corticosteroid or anticonvulsant therapy for at least 2 weeks prior to study treatment. Inhaled non-absorbable and topical corticosteroid use are permitted as indicated.\n4. . Patients may have prior placement of a properly functioning CNS shunt or Ommaya reservoir.\n5. . ECOG performance status 0 or 1, with no deterioration over the past 2 weeks, and expected survival time ≥ 3 months.\n6. . Women of child-bearing potential (WOCBP) and male patients should agree to take medically acceptable contraception measures while on study treatment and for 3 months following completion of study treatment. All WOCBP must have a negative pregnancy test at screening.\n7. . Patients with measurable CNS lesions must have at least one site of CNS lesion, which has not been previously irradiated, can be accurately measured at baseline as ≥ 10 mm in the longest diameter by MRI, and is suitable for accurate repeated measurements. Measurable extracranial lesions are not required. Patients with non-measurable CNS lesions must have at least one extracranial lesion, which has not been previously irradiated, can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except for lymph nodes which must have a short diameter ≥ 15 mm) by CT\u002FMRI, and is suitable for accurate repeated measurements.\n\nExclusion Criteria A:\n\n1. . Prior treatment with EGFR-TKIs (if EGFR-TKIs were used as adjuvant therapy, patients may be enrolled if the time from discontinuation to relapse meets the following requirements: \\>6 months for Cohort A, and \\>3 months for Cohorts B and C).\n2. . Positive for T790M mutation documented by central or local laboratory using an approved or validated test method, or documented positive KRAS or cMET.\n3. . Patients who have received any investigational drug, biological therapy, or immunotherapy for their malignant tumors within the past 21 days.\n4. . Patients who have had a major surgical procedure (excluding the need for placement of vascular access or a CNS shunt), or significant traumatic injury within 4 weeks of the first dose of study treatment, or have an anticipated need for major surgery during the study.\n5. . Presence of only leptomeningeal metastases (LM) disease confirmed by MRI and\u002For positive cerebrospinal fluid (CSF) pathology, with no brain metastases (BM).\n6. . Prior radiation therapy for CNS metastases that involves measurable or non-measurable sites of disease to assess efficacy.\n7. . Patients who have received radiation to more than 30% of the bone marrow within 2 weeks before the first dose of study treatment.\n8. . Patients currently receiving (or unable to stop use at least 1 week prior to receiving the first dose of study treatment) certain medications or herbal supplements that are known to be potent inhibitors or inducers of CYP3A4\u002F5 (see Appendix A).\n9. . Unmanageable nausea and vomiting, chronic gastrointestinal diseases, or prior gastric resection or surgical procedure that may interfere with adequate absorption of study drug.\n10. . History of concurrent and\u002For other active malignant tumors requiring treatment within 5 years of study treatment, excluding prior treated squamous cell carcinoma or basal cell carcinoma or carcinoma in situ.\n11. . History of any type of documented interstitial lung disease or radiation pneumonitis.\n12. . Presence of any severe or uncontrolled systemic disease or condition, including: (i) uncontrolled hypertension or diabetes; (ii) serious cardiac, pulmonary or renal disorders; (iii) active bleeding diatheses; (iv) any active type of bacterial, viral, fungal or other infection that would pose a significant risk to the patient in the opinion of the Investigator; or (v) active hepatitis B virus positive (defined as hepatitis B surface antigen (HBsAg) positive or hepatitis B core antibody (HBcAb) positive, and hepatitis B DNA positive (or detectable) or above the cut-off value) or positive HCV antibodies or positive HIV test result.\n13. . Women who are pregnant or lactating. WOCBP and fertile men with a WOCBP-partner not using adequate contraception measures.\n14. . Patients with unstable and symptomatic metastases: Any unstable and symptomatic CNS or distant metastasis that is not symptomatically controlled by prior surgery, radiotherapy or corticosteroid therapy within 2 weeks of initial study treatment.\n15. . Any unresolved toxicities from prior therapy, greater than Common Terminology Criteria for Adverse Events (CTCAE 5.0) Grade 1 at the time of starting study treatment, with exception of alopecia.\n16. . Patients with a significant cardiovascular disorder or condition, including any of the following:\n\n    1. Congestive heart failure (CHF) currently requiring treatment and patients with New York Heart Association (NYHA) Class III\u002FIV CHF (see Appendix B).\n    2. Need for antiarrhythmic drug therapy for a ventricular arrhythmia or patients with uncontrolled or unstable arrhythmias.\n    3. Severe conduction disturbance (e.g., second- or third-degree AV block).\n    4. Angina pectoris requiring treatment.\n    5. QTc interval \\> 450 msec (males) or \\> 470 msec (females).\n    6. History of congenital long QT syndrome, congenital short QT syndrome, Torsades de Pointes, or Wolff Parkinson White syndrome.\n    7. Left ventricular ejection fraction (LVEF) \\\u003C50% as determined by echocardiography or MUGA scan.\n    8. Myocardial infarction diagnosed within the past 6 months.\n17. . Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:\n\n    1. Absolute neutrophil count \\\u003C1.5 × 109\u002FL.\n    2. Platelet count \\\u003C100 × 109\u002FL (Transfusion-dependent patients are excluded from this study).\n    3. Hemoglobin \\\u003C90 g\u002FL.\n    4. Alanine aminotransferase (ALT) \\> 2.5 times the upper limit of normal (ULN) in the absence of documented metastases to liver or \\> 5 times the ULN in the presence of metastases to liver.\n    5. Aspartate aminotransferase (AST) \\> 2.5 times the ULN in the absence of documented metastases to liver or \\> 5 times the ULN in the presence of metastases to liver.\n    6. Total bilirubin \\> 1.5 times the ULN in the absence of metastases to liver or \\>3 times the ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or metastases to liver.\n    7. Creatinine \\>1.5 times the ULN concurrent with creatinine clearance \\\u003C50 mL\u002Fmin (measured or calculated by Cockcroft-Gault equation). Confirmation of creatinine clearance is only required when creatinine is \\>1.5 times the ULN.\n    8. If bone metastases are present and liver function is otherwise considered adequate by the Investigator, then isolated elevated alkaline phosphatase (ALP) is not an exclusion criterion.\n18. . History of hypersensitivity to active or inactive excipients of the study drug or drugs with a similar chemical structure or class to the study drug.\n19. . Judgment by the Investigator that the patient should not participate in the study if the patient is unwilling to comply with all study procedures and treatment.\n20. . History of recent stroke (\\\u003C6 months), or prior central nervous system injury that has persistent neurologic deficits that would affect neurologic assessments.\n21. . Significant medical or psychiatric illness that would interfere with the compliance to the protocol and ability to tolerate treatment.\n22. . Patients who have received any anti-neoplastic herbal medicines for their malignant tumors within the past 2 weeks.",{"count":81,"type":20},800,"OBSERVATIONAL","This study is a patient-centered, two-group, three-cohort, multi-center, prospective study to further evaluate the survival benefits and safety of zorifertinib as a first-line treatment in EGFRm+ advanced NSCLC patients with CNS metastases, and to compare the clinical value of zorifertinib with other epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs).",[62,63],"2026-02-06",{"date":87,"type":38},"2026-02-09",{"date":89,"type":38},"2025-12-29",{"date":91,"type":20},"2031-11",{"name":44,"class":45},34,""]